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Liraglutide in Preventing Delirium in Diabetic Elderly After Cardiac Surgery

ConditionDelirium, Postoperative
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age60+
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

This study aims to clarify the preventive effect of perioperative liraglutide application on postoperative delirium in elderly patients with Type 2 diabetes undergoing cardiac surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 60 years

Type 2 diabetes

Patients undergoing elective cardiac surgery

Disqualifiers

History of neurological or psychiatric disorders, such as schizophrenia, epilepsy, Parkinson's disease, severe dementia, etc

Patients with communication difficulties, such as severe visual, auditory, or speech impairments

History of central nervous system damage or surgery

Cardiac function NYHA Class IV

Trial design

Design model

Parallel

Treatments tested in this trial

  • Liraglutide injection

    Drug

    Subcutaneous injection of liraglutide: 0.6 mg administered the day before surgery, 1.8 mg administered post-anesthesia induction on the day of surgery, followed by 0.6 mg daily for the first three postoperative days.

  • Placebo injection

    Drug

    Subcutaneous injection of Placebo: the same volume as liraglutide administrated at the corresponding times.

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: Liraglutide GroupExperimental treatment 1 intervention
Group B: Vehicle GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of delirium

Confusion Assessment Method (CAM), or its variant for the Intensive Care Unit, known as CAM-ICU, is the tool used to assess the incidence of delirium. For CAM, the scale ranges from a minimum value of 11 to a maximum of 44, with higher scores indicating a worse outcome. In contrast, CAM-ICU does not utilize a numerical scale; it is a qualitative assessment designed to evaluate confusion without assigning specific values.

Time frame
One day before surgery and within the first seven days after surgery.

Secondary outcomes

1

The severity of delirium

The CAM-Severity Scale (CAM-S), available in both short-form and long-form versions, serves as a tool for assessing the severity of delirium. The scale extends from 0 to 7 in its short-form and from 0 to 19 in its long-form. Higher scores on the CAM-S are indicative of more severe outcomes.

Time frame
One day before surgery and within the first seven days after surgery.
2

Cognitive function

Minimum Mental State Examination (MMSE) is the tool used to assess cognitive function. The scale extends from 0 to 30, with higher scores indicating a better outcome.

Time frame
One day before surgery; one week after surgery or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
3

Anxiety

Generalized anxiety disorder-7 (GAD-7) is the tool used to assess anxiety. The scale extends from 0 to 21, with higher scores indicating a worse outcome.

Time frame
One day before surgery; one week after surgery or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.
4

Depression

Patient Health Questionnaire-9 (PHQ-9) is the tool used to assess depression. The scale extends from 0 to 27, with higher scores indicating a worse outcome.

Time frame
One day before surgery; one week after surgery or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Lead sponsor

Source ClinicalTrials.gov
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